National Centre for Pharmacoeconomics

National Centre for
Pharmacoeconomics

NCPE Ireland

Delta-9-tetrahydrocannabinol/Cannabidiol, THC/CBD (Sativex®)

Delta-9-tetrahydrocannabinol/Cannabidiol, THC/CBD (Sativex®) which is indicated as treatment for symptom improvement in adult patients with moderate to severe spasticity due to multiple sclerosis (MS) who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy.

 

Rapid Review

Commenced Completed Outcome
05/12/2012 04/01/2013  Full Pharmacoeconomic Assessment Recommended

Pharmacoeconomic Evaluation

Commenced Completed Outcome
11/07/2014*  26/09/2014 Reimbursement Not Recommended

*Formal assessment commenced following legislative changes.

The NCPE does not recommend reimbursement of Sativex® at the submitted price.

Summary

 

NCPE Assessment Process Complete
Rapid review commissioned 12/02/2018
Rapid review completed 03/04/2018
Rapid Review outcome A full pharmacoeconomic assessment is recommended to assess the clinical effectiveness and cost effectiveness of Sativex® compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by the HSE 20/04/2018
Pre-submission consultation with Applicant 25/09/2018
Submission received from Applicant 12/08/2019
Preliminary review sent to Applicant 10/02/2020
NCPE assessment re-commenced 01/12/2020
Preliminary review follow-up sent to Applicant 19/03/2021
NCPE assessment re-commenced 04/05/2021
Factual accuracy check sent to Applicant 08/06/2021
NCPE assessment re-commenced 21/06/2021
NCPE assessment completed 15/07/2021
NCPE assessment outcome The NCPE recommends that Sativex® not be considered for reimbursement unless cost effectiveness can be improved relative to existing treatments*.

Technical Summary

Plain English Summary

 

*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.